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  • Open Access
  • © 2017

Pharmacovigilance in the European Union

Practical Implementation across Member States

  • Innovative insights into incentives and impediments of practical implementation
  • Short, medium and long term recommendations to improve practical implementation of EU legislation
  • Hands-on insights into six EU member states
  • Includes supplementary material: sn.pub/extras

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Table of contents (7 chapters)

  1. Front Matter

    Pages I-XIV
  2. Introduction

    • Michael Kaeding, Julia Schmälter, Christoph Klika
    Pages 1-10Open Access
  3. Pharmacovigilance

    • Michael Kaeding, Julia Schmälter, Christoph Klika
    Pages 11-16Open Access
  4. The EU Pharmacovigilance System

    • Michael Kaeding, Julia Schmälter, Christoph Klika
    Pages 17-34Open Access
  5. Timely and Correct Transposition of Pharmacovigilance across Member States

    • Michael Kaeding, Julia Schmälter, Christoph Klika
    Pages 35-43Open Access
  6. Practical Implementation in Six Member States

    • Michael Kaeding, Julia Schmälter, Christoph Klika
    Pages 45-102Open Access
  7. Challenges and Best Practices in Perspective

    • Michael Kaeding, Julia Schmälter, Christoph Klika
    Pages 103-114Open Access
  8. Conclusions and Recommendations

    • Michael Kaeding, Julia Schmälter, Christoph Klika
    Pages 115-124Open Access

About this book

This book is open access under a CC BY 4.0 license.

The book presents the results of an in-depth comparative study assessing the implementation of the EU Pharmacovigilance Directive in six EU Member States. By going beyond legal transposition and instead focusing on practical implementation, this study aims to close a gap in EU compliance research. Based on qualitative interviews with relevant actors in Germany, Poland, Portugal, France, Finland and the UK, the authors identify perceived challenges and best-practices, issue recommendations, and thereby contribute to a better understanding of the factors that incentivize or impede the practical implementation of EU law at the national level.



Authors and Affiliations

  • Institut für Politikwissenschaft, Universität Duisburg-Essen Institut für Politikwissenschaft, Duisburg, Germany

    Michael Kaeding, Julia Schmälter, Christoph Klika

About the authors

Dr. Michael Kaeding is Professor for European Integration and European Union Politics at the Department of Political Science of the University of Duisburg-Essen, Germany and holds an ad personam Jean Monnet Chair in "Understanding EU Decision Making and Member States´ Compliance with EU Policies".  


Julia Schmälter is a research assistant at the Jean Monnet Chair for European Integration and European Union Politics at the Department of Political Science at the University of Duisburg-Essen.


Christoph Klika is a lecturer at the Department of Political Science at the University of Duisburg-Essen.




Bibliographic Information

Buy it now

Buying options

Softcover Book USD 59.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Other ways to access